Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

The tax went into effect in 2013, but in the 114th Congress Paulsen helped pass a two-year suspension through Jan. 1, 2018 under the Consolidate Appropriations Act of 2016,

Industry trade association AvadMed was quick to put out a statement after the 5-year extension was proposed in the House as it has been adamantly urging a full repeal of the tax, citing hindered innovation, deterred job creation, among other issues.

AvadMed President and CEO Scott Whitaker applauded the proposed extension as “an important first step to provide medical technology innovators with confidence that this tax will not go back into effect” and urged Congress to adopt it “immediately.”